Medical Director Medical Affairs Companion Diagnostics Oncology

Profile

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at

www.astellas.com

This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.

Purpose and Scope:

The Companion Diagnostic Director, Medical Affairs US, is accountable for the development and execution of medical and scientific strategies for the zolbetuximab and the associated novel companion diagnostic assay. The Companion Diagnostic Director is responsible for:

development and coordination of the overarching Biomarker and CDx strategy for Zolbetuximab and implementation of Zolbetuximab-related tactics

creation and management of internal product/diagnostic strategy and training

strategic oversight and execution of data generation activities and other MA tactics related to the CDx

review and endorsement of, and in some cases creation of scientific exchange materials, product launch planning/operations, and strategic congress planning, including collection and assessment of external medical insights to shape medical strategies, especially those related to the CDx

collaboration with key stakeholders across the company to support business objectives for the US

assessment of external medical environment perspectives and informing of medical strategies, including global strategies.

Essential Job Responsibilities:

Prepare for the US launch of zolbetuximab and the novel CDx in gastric/GEJ cancer

Support the development and execution of solid US strategic medical plans for zolbetuximab and the Companion Diagnostic within the TA that are aligned with the global Core Medical Plan (CMP)

Develops the MSL strategy for companion diagnostics launch and medical education and ensures it's pull through along with the field directors and the national directors.

Leads Evidence Generation activities to support the launch of the companion diagnostic

Accountable for oversight and execution of MA-sponsored clinical studies, as applicable

Drive scientific and medical development and approval of sound study synopsis, protocols and study reports, including health economic & outcomes research (HEOR) related studies, ensuring clinical and scientific accuracy

Align with peer leaders in the Commercial organization and cross-functional teams, providing strategic medical direction to support the needs of the business

Demonstrate ability to collaborate and lead within matrix product/TA teams across multiple disciplines

Provide medical expertise and approval of promotional materials

Provide medical expertise and approval of non-promotional medical materials, including but not limited to slide presentations, local dossiers, health outcomes models, etc.

Review and approve all standard and custom Medical Information response letters

Initiate and support medical advisory boards within area of responsibility to understand and shape medical strategies

Partner with medical science liaison (MSL) team in the field, effectively translating insights into regional and global strategy

Collaborate with Regulatory Affairs and Pharmacovigilance in the development of product labeling and periodic safety reports, as applicable

Lead scientific review of investigator sponsored research (ISR) proposals in the TA; may chair Regional ISR Committee if applicable

Provide medical expertise related to new product licensing and acquisition opportunities for the Americas

Foster a culture of 100% compliance and embody One Astellas and the Astellas Way

Quantitative Dimensions:

The Companion Diagnostic Director provides medical and scientific guidance for one or more products within the TA including accountability for MAA product/TA strategies and execution. The Companion Diagnostic Director is part of a high performing medical team with direct budget responsibilities of to $10M annually, including 5-10 data generation projects and 10 medical tools annually. The results produced by the Companion Diagnostic Director must be scientifically sound and in compliance with applicable regulations. The Companion Diagnostic is accountable for CMP deliverables within timelines and budget and will demonstrate solid leadership and executive presence with both internal and external executive leaders.

Organizational Context

The Companion Diagnostic reports to the Senior Director, Oncology, and will work within multiple cross-collaborative project teams and have matrix responsibilities across the Americas region and broader Astellas global organization. The Companion Diagnostic Director will collaborate with the following colleagues:

MA: Vice Presidents, Executive Medical Directors /CMT leads, Senior Medical Directors/CMT members, Executive/Senior Director HEOR, Field Medical

M&D: Executive Directors; Senior Directors - including Regulatory, Pharmacovigilance, statistics and Development

Commercial/VSAS: Executive/Senior Directors/Directors

Other: Senior leaders - Government Affairs, Legal, Ethics & Compliance, Business Development

External: Key External Experts, Executive leadership of Astellas partners, and medical organizations

Requirements

Qualifications Required

MD, DO, PhD, or PharmD

Minimum 8 years Medical Affairs/Development experience working in the pharmaceutical industry and/or minimum 5 years clinical or academic experience following residency training

Minimum 5 years relevant leadership experience leading companion diagnostics activity efforts within a Pharma organization

Strong understanding of industry trends, the regulatory environment, as well market access paths for companion diagnostics

Experience in working in matrix organization collaborating with medical, clinical, regulatory, health economic & outcome research, epidemiology, medical information, commercial and other organizational partners to deliver results

Solid scientific analytical and problem-solving skills, strategic capabilities, project management and planning and organizational skills

Ability to communicate effectively, including scientific concepts, both in writing and in oral presentations

Ability to design and conduct various phases of clinical trials, including ability to critically review and analyze study designs

Ability to collaborate within matrix structured product team across multiple disciplines

Ability to effectively engage both internal and external stakeholders, customers and collaboration partners.

Demonstrated ability to collaborate and build strategic alignment within the Medical Affairs community and across functions (e.g., Commercial).

Fluent in written and verbal English

Approximately 20% travel required

Qualifications Preferred

10 years Medical Affairs relevant experience within the pharmaceutical industry

Medically Qualified with post graduate qualification and specialization in appropriate therapeutic specialty preferred such as Pathology or Oncology

Board Certified in relevant therapeutic area

Active medical license

Experience in medical research

Extensive knowledge of Americas healthcare delivery systems (e.g., accountable care, managed care, pharmacy benefit management, government [Medicare, Medicaid]) and solid understanding of policy issues)

Demonstrated strong interpersonal relationship and collaboration skills working within cross- functional executive leadership teams

Thorough understanding of FDA/PhRMA, OIG, Health Canada/Innovative Medicines Canada, ANVISA/ANS and other guidelines as they relate to HEOR and Medical Affairs

Benefits

Medical, Dental and Vision Insurance

Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down

401(k) match and annual company contribution

Company paid life insurance

Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions

Long Term Incentive Plan for eligible positions

Referral bonus program

Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans.

*LI-CH1

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled

Location

IL, Northbrook

Category

Medical Affairs

Company info

Astellas Us, LLC
Website : https://www.astellas.com/us/